Advisers to the United States Food and Drug Administration (FDA) have overwhelmingly backed the authorization of Novavax Inc’s COVID-19 vaccine for adults. A panel of outside vaccine experts on Tuesday voted 21-0 with one abstention, recommending the use of the jab for people aged 18 and above. The FDA will now decide whether to greenlight Novavax as the fourth coronavirus vaccine for adults in the US. A decision is not expected immediately.
Novavax Chief Commercial Officer John Trizzino said the documents with details on the shot’s manufacturing process were submitted to the agency last week and that they were still being reviewed. “We hopefully expect to have product in the US in our warehouse by the end of June,” he said in an interview.
Trizzino said that the Maryland-based company has plans to ship millions of doses made by its partner, the Serum Institute of India, as soon as the FDA gives an approval.
Tag: Novavax
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COVID: US experts recommend Novavax vaccine
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Mixing shots a bad idea; India may not meet Dec 31 target: SII founder
Pune (TIP) : The Serum Institute of India is unlikely to be able to secure a licence for its version of the highly efficacious coronavirus vaccine developed by US-based company Novavax, the Pune-based vaccine maker’s chairman said on Friday, when he also urged caution on mixing of doses, said booster shots may be needed for those vaccinated over six months ago, and that the expectation that all Indians will be vaccinated by the end of 2021 was unlikely to be achieved.
Cyrus Poonawalla, 80, who founded SII – now the world’s largest vaccine maker by volume – was speaking at an event in Pune, where he credited the Centre for easing regulatory processes for vaccine makers at a difficult time. He, however, stressed that the ideal gap between two doses of Covishield, which his company makes, was two months, and criticised the government for banning the export of doses.
On the vaccination target to reach all Indians by 2021, Poonawalla said: “We are yet to increase our production to 10 crore (100 million) vaccines. No single company in the world can produce 10 crore vaccines in a month. We have promised about 110-120 crore doses annually because we invested in it prior. So you can do the math now. If other manufacturers produce 1-2 crores every month then the production would increase accordingly.”
The SII founder also said it was a “bad move by the government” to embargo exports of vaccines. “My son (SII CEO Adar Poonawalla) asked me not to open my mouth. But it is my view that exports ought to be opened,” Poonawalla said, citing SII’s supply commitments.
Over 150 countries are dependent on SII for vaccines and are blaming the company for stopping the supply during a crucial period, he said, before adding that these countries have paid “crores” in advances. The Bill and Melinda Gates Foundation and World Health Organisation (WHO) have given it ?5,000 crore which, Poonawalla said, he offered to return. He hinted that they declined his offer in the hope that the Indian government will lift the ban soon.
India banned vaccine exports in April when the second wave of the pandemic began to peak and the need to vaccinate people in the country at a greater pace was felt acutely.
Poonawalla, however, credited the Centre for easing regulatory processes. “I must stress that my difficulties are much reduced under the Modi government. Definitely, I am not the one to give lip sympathy to government ministers but certainly, one of the major reasons why we could launch our Covid vaccine so quickly was because of the forthcoming grant of permissions, encouragement to industries and reduction of ‘Licencing Raj’. We have now got a drug controller who responds in the evening hours,” Poonawalla said.
SII-manufactured Covishield accounts for close to 90% of all coronavirus vaccine doses administered in India. In mid-July, the Union government announced that it had placed orders for 375 million doses of Covishield at a rate of ?205 per dose. These doses will be supplied between August and December. The Union government recently told Parliament that the company will produce 150 million doses a month beginning next month.
Source: HT
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Patent waivers alone may not lead to quick vaccine access, say experts
The waiving off of patents alone is unlikely to help improve vaccine availability anytime soon, scientists, legal experts and pharma industry executives said, pointing to the complicated technical know-how, raw materials and infrastructure required to make vaccines while ensuring they are as safe and effective as the original developer intended it to be. Several countries, including the US, France and the European Union are considering backing efforts countries such as India and South Africa for a global waiver of coronavirus vaccine patents to boost supplies. While such a move could well be the first step in broadening access, patents alone do little to allow someone else to make biological therapeutics such as vaccines, unlike in the case of generic drugs, which are chemicals and can be replicated more easily with a recipe book of sorts. “Patents are a way of protection of your intellectual and commercial information, speaking from a legal point of view. But just by reading a patent, does not necessarily offer the ability to replicate the product or the process, because while a patent does share a lot of the generic information, it protects the specifics, and it is not a self-guide,” said Prabuddha Kundu, co-founder and managing director at Premas Biotech, which is working on an oral Covid-19 vaccine.
To understand the challenge, consider the case of some coronavirus vaccines: AstraZeneca and J&J’s vaccines involve a bio-engineered adenovirus that expresses the Sars-Cov-2’s spike protein; Novavax’s vaccine consists directly of the spike protein that has been cultured and grown in moth cells in labs.
“A chemical entity and a biological entity are very different. Even a simple protein, for example, is hundred times more complex or has more components than a drug like, say, paracetamol. There can be many ways to make paracetamol, and it would turn out to be exactly that but even if there were few ways to produce the protein, the final product varies in its final shape and form,” added Kundu.
For that, he added, “you must understand the process so well, that every time you carry it out, you end up with exactly the same product. In many situations in biologics, the process is the product”.
Legal experts in the pharma field said this constitutes know-how, which often is a trade secret. “There is a clear divide between a patent and a trade secret. The technical know-how is proprietary. TRIPS provides for protection of undisclosed information, which would not be found in patents,” said Dev Robinson, partner and head, Intellectual Property, at Shardul Amarchand Mangaldas.
TRIPS refers to Trade-Related Aspects of Intellectual Property Rights agreement under the World Trade Organization (WTO), the specific framework that India and South Africa have sought waivers under.
Source: HT